The TGA has finally released its consultation paper on the proposed fees & charges model for the 2023-24 Financial year (FY24).
Although most fees and charges are proposed to increase by an inflation-based indexation of 5.2%, there are a number of special additional increases proposed particularly for medical devices.
Annual charges for medical devices are proposed to increase by 12.33%, meaning that:
- annual charges for Class III devices will increase by $153 from $1,275 to $1,394
- annual charges for Class IIa or IIb devices will increase by $120 from $975 to $1,095
However, one of the biggest surprises in this year’s consultation paper is a significant proposed increase to fees for several key medical device activities, as identified in the following table.
Medical Device fees could be increasing by up to 280% for the next Financial Year
* Includes proposed additional 5.2% indexation increase
Most notably, the fees charged for Level 2 Application Audits for Class III non-IVD medical devices, as well as variation applications for most devices, are more than doubling.
However, sponsors of Class 3 IVD devices are set to experience the biggest increases, with the fees for Level 2 Application Audits and variation applications more than tripling!
The increase in Level 2 Application Audit fees alone is predicted to contribute an additional $4.5m to TGA’s revenue for FY24.
If the proposed fee structure goes ahead and is signed-off by Government, the new fees & charges are expected to take effect from 1 July this year.
If you were planning on making any of the above submissions this year, it could be advantageous to submit your applications before the end of June to take advantage of considerably lower fees.
Commercial Eyes are available to assist with making these submissions before the end of the financial year, please contact our experienced team at [email protected].